Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0883-2016 | Class II | Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0882-2016 | Class II | Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the... | Howmedica Osteonics Corp | HSB | |
| Z-0881-2016 | Class II | Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0880-2016 | Class II | Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the... | Howmedica Osteonics Corp | MAY | |
| Z-0879-2016 | Class II | Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the... | Howmedica Osteonics Corp | MAY | |
| Z-0878-2016 | Class II | Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0877-2016 | Class II | Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the... | Howmedica Osteonics Corp | MAY | |
| Z-0876-2016 | Class II | Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0875-2016 | Class II | Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0874-2016 | Class II | Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the... | Howmedica Osteonics Corp | MAY | |
| Z-0873-2016 | Class II | Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of... | Howmedica Osteonics Corp | MAY | |
| Z-0872-2016 | Class II | Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the... | Howmedica Osteonics Corp | MAY | |
| Z-0871-2016 | Class II | Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0870-2016 | Class II | Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | HSB | |
| Z-0869-2016 | Class II | Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization... | Howmedica Osteonics Corp | MAY | |
| Z-0868-2016 | Class II | Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the... | Howmedica Osteonics Corp | HSB | |
| Z-0867-2016 | Class II | Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary... | Howmedica Osteonics Corp | MAY | |
| Z-0788-2016 | Class II | Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in... | Biomet France | LYC | |
| Z-1034-2016 | Class II | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8... | Medtronic, Inc. | KNT | |
| Z-1033-2016 | Class II | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5... | Medtronic, Inc. | KNT | |
| Z-3035-2017 | Class II | LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD... | Magellan Diagnostics, Inc. | DOF | |
| Z-3117-2017 | Class II | Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic... | Zimmer GmbH | HAW | |
| Z-1698-2017 | Class II | AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing... | AGFA Healthcare Corp. | IZL | |
| Z-0865-2016 | Class II | Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC... | Cook Incorporated | DYB | |
| Z-0860-2016 | Class II | Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered... | Hill-Rom Inc. | FRJ | |
| Z-0910-2016 | Class II | Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0909-2016 | Class II | Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0908-2016 | Class II | Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0907-2016 | Class II | Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0906-2016 | Class II | Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0905-2016 | Class II | Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0904-2016 | Class II | Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0903-2016 | Class II | Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0902-2016 | Class II | Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0901-2016 | Class II | Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0900-2016 | Class II | Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0899-2016 | Class II | Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0898-2016 | Class II | Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0897-2016 | Class II | Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0896-2016 | Class II | Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0895-2016 | Class II | Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0894-2016 | Class II | Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0893-2016 | Class II | Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0892-2016 | Class II | Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0891-2016 | Class II | Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-0890-2016 | Class II | Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope | Integrated Medical Systems Inc | GCQ | |
| Z-0889-2016 | Class II | Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope | Integrated Medical Systems Inc | GCQ | |
| Z-2137-2016 | Class II | HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with... | Ergoactives, LLC | IRT | |
| Z-0861-2016 | Class II | Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector... | Centurion Medical Products, LP | FPA | |
| Z-1018-2016 | Class III | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack... | LivaNova USA, Inc. | DWF |
